Sr. Manager, Mechanical Engineering

OrthAlign, Inc., a Smart Technologies, growing medical device company, has an immediate opening for a Sr. Manager, Mechanical Engineering. 
The Sr. Manager, Mechanical Engineering is responsible for managing a team of mechanical engineers and designers and coordinating tasks across multiple medical device projects.

You will:

• Support the team creation of detailed, complete, and accurate specification to meet system and component level requirements.


• Define, manage, and communicate comprehensive and accurate project timelines.


• Define, develop, and communicate testing strategies.


• Effectively manage design changes including collaborative development of adoptions and justifications where applicable.


• Support the definition and development of design verification and validation plans, and coordinate and drive timely execution. 


• Lead and support product risk assessments.


• Drive effective cadence of technical design reviews with required, qualified staff.


• Provide continual monitoring of projects and direction to the Engineering team.


• Lead and mentor team of mechanical engineering professionals.


• Develop work breakdown structures for complex system-level projects and ensure optimal use of staff; manage and respond to resource needs and bottlenecks.


• Work closely with Program Management/Systems Engineering to ensure technical workstreams are aligned with timelines and issues/blockers are raised and resolved in a timely manner. 


• Identify and develop suppliers. Develop and execute DFM strategies.


• Possess managerial toughness to ensure staff are executing at a high level.


• Organize and manage sustaining projects while providing support for new product projects.


• Manage the model shop. Ensure full capacity utilization and continuous improvement of processes and capabilities.


• Interface with marketing and sales personnel and collaborate effectively with cross-functional stakeholders.


• DFM, DFI, and design for reliability expertise.


• Determine design direction based on results of planned feasibility studies.


• Dimensioning and tolerancing. Mating part analysis. GD&T including knowledge of ASME and ISO standards,

You need:

• Master's degree in mechanical engineering with medical device experience.
  


• 10+ years of experience in mechanical design of medical device products.


• Strong proficiency using MS Office Suite (e.g., Word, Excel, PowerPoint).


• Excellent attention to detail, producing high quality output.


• Ability to apply sound judgment when making decisions and communicating with peers and management.


• Extensive experience in the development, manufacturing, and commercialization of medical device products (surgical devices preferred).


• Strong background navigating ISO 13485 design control requirements of Design Controls.


• Machine design and machine shop best practices and know-how.


• Knowledge of and experience with ASME and ISO and key standards for medical device dimensioning, tolerancing, and drafting.


• Experience leading, mentoring and developing teams. 


• Experience in mechanical and surgical devices required (Orthopedics a plus).


• Experience with electromechanical products a plus.

We offer:

• Innovative products


• Awesome benefits


• Great coworkers


• An evolving, engaging culture and workplace

It is an exciting time at OrthAlign - make your next career move with us!

Please note that we are unable to provide any type of sponsorship at this time.